FDA 483 - SM Biomed Sdn Bhd - March 23, 2018

An FDA inspection of SM Biomed Sdn. Bhd. in Sungai Petani, Malaysia, revealed a significant issue regarding the validation of a printer used for imprinting critical information onto API templates. The firm lacked documented evidence that the specific printer in use had been validated, with a discrepancy noted between the validated printer's identification and the printer actually utilized. This indicates a potential control weakness in their labeling process for active pharmaceutical ingredients.